WO2020017790A1 - Film-coating composition with improved damp-proofing property and tablet coated with same - Google Patents

Film-coating composition with improved damp-proofing property and tablet coated with same Download PDF

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Publication number
WO2020017790A1
WO2020017790A1 PCT/KR2019/008107 KR2019008107W WO2020017790A1 WO 2020017790 A1 WO2020017790 A1 WO 2020017790A1 KR 2019008107 W KR2019008107 W KR 2019008107W WO 2020017790 A1 WO2020017790 A1 WO 2020017790A1
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coating
composition
weight
film
film coating
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PCT/KR2019/008107
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French (fr)
Korean (ko)
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이경호
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주식회사 스마코
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Publication of WO2020017790A1 publication Critical patent/WO2020017790A1/en

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    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L33/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
    • C08L33/04—Homopolymers or copolymers of esters
    • C08L33/06—Homopolymers or copolymers of esters of esters containing only carbon, hydrogen and oxygen, which oxygen atoms are present only as part of the carboxyl radical
    • C08L33/10—Homopolymers or copolymers of methacrylic acid esters
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L39/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions of derivatives of such polymers
    • C08L39/04—Homopolymers or copolymers of monomers containing heterocyclic rings having nitrogen as ring member
    • C08L39/06—Homopolymers or copolymers of N-vinyl-pyrrolidones
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D129/00—Coating compositions based on homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal, or ketal radical; Coating compositions based on hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Coating compositions based on derivatives of such polymers
    • C09D129/02—Homopolymers or copolymers of unsaturated alcohols
    • C09D129/04—Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D7/00—Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
    • C09D7/40—Additives
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D7/00—Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
    • C09D7/40—Additives
    • C09D7/60—Additives non-macromolecular
    • C09D7/61—Additives non-macromolecular inorganic

Definitions

  • the present invention relates to compositions for film coating tablets and to tablets coated with such film coating compositions.
  • the present invention can be coated at a high speed can significantly reduce the time required for the coating, and relates to a film coating composition and a tablet coated with such a composition having excellent moisture-proof coating.
  • an aqueous film coating using a water-soluble polymer as a coating agent is often performed for the purpose of protecting uncoated tablets and improving stability and appearance.
  • the film coating composition should have a desirable effect on ensuring the stability of the coated tablet.
  • the film coating has excellent moisture proofing ability.
  • excellent moisture and coating speeds are often arranged so that it is difficult to shorten the coating process and at the same time have excellent moisture resistance.
  • the problem to be solved by the present invention is to provide a film coating composition that can be quickly coated, advantageous for securing the stability of the coated uncoated tablet, and improved coating layer appearance stability such as cracking.
  • the present invention is to provide a film coating composition capable of providing a quick coating and excellent moisture proof.
  • a further problem to be solved by the present invention is to provide a tablet coated with such a film coating composition.
  • the present application comprises a coating polymer of 35-55% by weight relative to the total weight of the composition
  • the coating polymer is a polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer
  • the poly The content of the vinylpyrrolidone and methacrylic acid copolymer is 0.35 to 0.65 parts by weight relative to the polyvinyl alcohol content, respectively, and provides a composition for film coating, preferably a composition for tablet film coating.
  • the content of the polyvinylpyrrolidone and methacrylic acid copolymer in the composition is 0.4 to 0.6 parts by weight relative to the polyvinyl alcohol content, respectively.
  • polyvinyl alcohol, polyvinylpyrrolidone, and methacrylic acid copolymer are used as the coating polymer by weight of 2: 0.9-1.1: 0.9-1.1 (polyvinyl alcohol: polyvinylpyrrolidone: methacrylic acid copolymer) by weight. do.
  • methacrylic acid copolymer type C methacrylic acid copolymer type B, type A or a mixture thereof
  • type C is most preferable for the above purposes of the present invention.
  • copovidone vinylpyrrolidone-vinylacetate copolymer
  • the present application is 35-55% by weight of the coating polymer (polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer), 13-33% by weight of the composition for the film coating composition
  • a composition for film coating is provided comprising titanium, 15-30 wt% talc and 0.2-8 wt% plasticizer.
  • the present application is 35-55% by weight of the coating polymer (polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer), 13-33% by weight of the composition for the film coating composition Titanium, 15-30 weight percent talc, 0.2-8 weight percent plasticizer, and the balance (e.g. 0.1-8 weight percent) other additives (any one or more selected from the group consisting of pigments, lecithin, and the like) To provide a film coating composition.
  • the coating polymer polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer
  • Ti titanium
  • talc 15-30 weight percent talc
  • plasticizer e.g. 0.1-8 weight percent
  • other additives any one or more selected from the group consisting of pigments, lecithin, and the like
  • the film coating composition according to the present invention can increase the content of the composition in the coating liquid in order to shorten the coating time, and to form a good film coating layer.
  • the composition is used in combination with the coating solvent to be 25-35% by weight based on the final coating solution. More preferably, the composition is used in combination with the coating solvent to be 28-32% by weight based on the final coating solution. Most preferably, the composition is used in admixture with a coating solvent to be 29-31% by weight based on the final coating solution.
  • the film coating composition according to the present invention is to prepare a coating liquid using water, preferably purified water as a coating solvent, wherein the mixing ratio of the coating solvent and the composition is as mentioned above.
  • the inventors have conducted a variety of studies, using the film coating composition can significantly increase the film coating speed during film coating, confirming that there is a significant improvement in the stability and appearance of the coated tablets to complete the present invention It was.
  • the film coating composition of the present invention is excellent in the moisture absorption prevention effect.
  • the film coating composition according to the present invention includes a lecithin that serves to smooth the film coating surface with the other additives, and to soften the film.
  • the film coating composition of the present invention may further include colored pigments in addition to titanium oxide, which is a white colorant.
  • colored pigments in addition to titanium oxide, which is a white colorant.
  • dyes of aluminum lake series may be used.
  • a plasticizer may be used polyethylene glycol, triethyl citrate, propylene glycol and the like.
  • the polyethylene glycol is preferably polyethylene glycol 4000, polyethylene glycol 6000, and the like, and polyethylene glycol 6000 is particularly preferable for various purposes of the present invention.
  • the polyvinyl alcohol is preferably polyvinyl alcohol having a viscosity of 4-6 mPas when the viscosity is measured in a 4 wt% aqueous solution at 20 ° C.
  • the polyvinylpyrrolidone is preferably polyvinylpyrrolidone K-15, K-17, K-25, K-30, or the like.
  • the hypromellose is hypromellose 2910 is preferred, when the viscosity is measured by 20% aqueous solution of 2% by weight hypromellose having a viscosity of 10-20 mPas Is more preferred for various purposes of the present invention.
  • the present invention provides a film coating composition and a tablet coated with such a film coating composition that can be quickly coated, advantageous to secure the stability of the coated uncoated tablet, and improves the appearance stability of the coating layer such as cracking. .
  • FIG. 1 to 3 are results of stability evaluation of Samples A to E of Experimental Example 1.
  • FIG. 1 is a photograph of the external changes of the tablet
  • Figure 2 is a result of measuring the degree of discoloration of the tablet
  • Figure 3 is a result of measuring the degree of cracking of the tablet.
  • FIG. 4 to 6 are evaluation results of the composition for quick plus film coating.
  • FIG. 4 is a photograph of these external changes
  • FIG. 5 is a result of measuring color change of the tablet
  • FIG. 6 is a result of evaluating their degree of hygroscopicity.
  • the viscosity mentioned below is the viscosity of the solution obtained by viscosity measurement for about 1 minute with a BROOKFIFLD DVE viscometer (spindle RV S02, 60 rpm).
  • Comparative example 1 tap shield white 21W002
  • Comparative Example 1 To Comparative Example 1 was prepared a film coating composition in the composition and content of Table 1.
  • Raw material name Purpose of Mixing amount Polyvinyl alcohol Coating 40.0 Titanium oxide Colorant (pigment) 25.0 Polyethylene Glycol 3350 Epidermal supplements 20.2 Talc Epidermal supplements 14.8 total 100
  • the composition was mixed with purified water to attempt a film coating to find a suitable coating solution concentration.
  • the composition has a high viscosity when it exceeds 25% by weight relative to the total weight of the coating liquid, and the spraying is difficult, and even when sprayed, the surface is too rough, which is inappropriate for film coating. It was.
  • the suitable coating solution concentration of Comparative Example 1 was about 20% by weight based on the total weight of the coating solution, and the viscosity was about 90 cp.
  • a coating solution was prepared by mixing 50 parts by weight of the coating composition and 200 parts by weight of purified water, and using a coating machine, BGB. Sample tablets were coated as shown in Table 2 using -1.
  • the coating weight was 10 mg, the coating weight gain was 2%, and the tablet weight was 527 mg after coating at 527 mg.
  • the total coating time was 15 minutes and the average spray rate was 4.8 g / min. As a result, about 15 minutes were required to coat 10 mg with the composition.
  • a coating solution was prepared by mixing 15 parts by weight of the coating composition and 35 parts by weight of purified water, and sample tablets were coated using BGB-1 as a coater as shown in Table 4 below.
  • the coating weight was 36 mg, the coating weight gain was 5%, and the tablet weight was 714 mg after coating at 714 mg.
  • the total coating time was 35 minutes and the average spray rate was 7.2 g / min. As a result, about 35 minutes were required to coat 36 mg with the composition. Many sticking phenomenon occurs during the coating process, so it is not easy to set the coating process, and the coating takes a long time.
  • the composition was mixed with purified water to attempt film coating to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight relative to the total weight of the coating solution.
  • the viscosity of the coating solution was about 99 cp.
  • a coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water, and sample tablets were coated using BGB-1 using a coater as shown in Table 6 below.
  • the coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 707 mg after coating at 707 mg.
  • the total coating time was 9 minutes and the average spray rate was 8.0 g / min. As a result, about 9 minutes were needed to coat 35 mg with the composition.
  • Raw material name Purpose of Mixing amount Remarks Titanium oxide Colorant (pigment) 24.5 Polyvinyl alcohol Coating 22.76 Polyvinylpyrrolidone Coating 22.76 K-30 Talc Epidermal supplements 21.5 lecithin Epidermal supplements 2.0 Soy Lecithin Xanthan Gum Epidermal supplements 0.48 Aluminum Lake Pigment Colorant (pigment) Remaining amount total 100
  • the composition was mixed with purified water to attempt film coating to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight relative to the total weight of the coating solution.
  • the viscosity of the coating solution was about 120 cp.
  • a coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water.
  • the coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 707 mg after coating at 707 mg.
  • the total coating time was 9 minutes and the average spray rate was 8.0 g / min. As a result, about 9 minutes were needed to coat 35 mg with the composition.
  • the composition was mixed with purified water to attempt film coating to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight relative to the total weight of the coating solution.
  • the viscosity of the coating solution was about 125 cp.
  • a coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water.
  • the coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 707 mg after coating at 707 mg.
  • the total coating time was about 9 minutes and the average spray rate was 8.0 g / min. As a result, about 9 minutes were needed to coat 35 mg with the composition.
  • Comparative Example 1 Uncoated film coating was performed in the same manner as in Comparative Example 1 while replacing a portion of polyvinyl alcohol with polyvinylpyrrolidone. Substitution ratios of the polyvinylpyrrolidone were as shown in Table 11 below.
  • Sample name % Polymer Solute fraction (%) Solution viscosity (cp) Coating amount (%) Polyvinyl alcohol Polyvinylpyrrolidone Sample A (Comparative Example 1) 100 0 20 90.0 4 Sample B 75 25 20 120.0 4 Sample C 50 50 30 352.0 4 Sample D 25 75 30 208.0 4 Sample E 0 100 30 152.0 4
  • FIGS. 1 is a photograph of the external changes of the tablet
  • Figure 2 is a result of measuring the degree of discoloration of the tablet
  • Figure 3 is a result of measuring the degree of cracking of the tablet.
  • polyvinylpyrrolidone was found to be somewhat vulnerable to discoloration. However, specifically, when the content of polyvinyl alcohol and polyvinylpyrrolidone were mixed in a similar ratio, discoloration stability was relatively good.
  • the samples A, B, and C had no cracking, and the coating substrate melted and cracked only in the samples D and E having a higher content of polyvinylpyrrolidone than polyvinyl alcohol. Seemed.
  • Comparative Examples and Examples were prepared as shown in Table 12 below, and for the purpose of comparative evaluation, uncoated tablets were used for uncoated tablets (coated tablets of impact vitamin premium tablets, a multivitamin preparation).
  • Each coating composition is shown in Table 13 (primary coating substrate) and 14 (secondary coating substrate). Water was used as a coating solvent for dissolving or finely suspending the composition.
  • the coating liquid was mixed with water so that the tap shield clear (71C152) was 8.5 wt%, the tap shield white was 20 wt%, the tap shield quick was 30 wt%, and the tap shield quick plus was 30 wt% based on the total weight of the coating liquid.
  • Each coating condition was as Table 15 below.
  • the tablet weight was 700 mg after coating at 707 mg.
  • the total coating time was about 9 minutes.
  • the tablet weight was 742 mg after coating at 707 mg.
  • the total coating time was about 40 minutes.
  • about 40 minutes were required to coat 35 mg with the composition.
  • the coating composition of the tab shield white when the coating composition content of the coating liquid exceeds 12% by weight, spraying is not good and sticking occurs, and moisture proofing power is also not very good.
  • Tablet weights were 742 mg after coating at 707 mg for the tab shield white (21W002). Total coating time was about 20 minutes. As a result, about 20 minutes were required to coat 35 mg with the composition. In the case of the tap shield white (21W002) coating composition, a sticking phenomenon occurs during the coating, and the coating quality is poor, so that it is difficult to increase the spraying speed.
  • the tablet weight was 742 mg after coating at 707 mg.
  • the total coating time was about 40 minutes.
  • about 20 minutes were required to coat 35 mg with the composition.
  • the tap shield white (22W005) coating composition a sticking phenomenon occurs during coating, and the coating quality is poor, so that it is difficult to increase the spraying speed.
  • Tablet weights from 707 mg to 742 mg after coating for TapShield Quick and TapShield Quick Plus were about 9 minutes. As a result, about 9 minutes were needed to coat 35 mg with the composition.
  • the film coating composition according to the present invention can be coated in a short time to significantly shorten the coating process while showing excellent stability in protecting the uncoated at the same time.

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Abstract

The present invention relates to a film-coating composition and a tablet coated therewith, the film-coating composition allowing rapid coating, assuring stability of the plain tablet (uncoated tablet) that is coated, and improving stability of the appearance of the coating layer from cracking and the like. In particular, the film-coating composition of the present invention is very effective in the prevention of moisture absorption.

Description

방습성이 개선된 필름 코팅용 조성물 및 이를 코팅한 정제Film coating composition with improved moisture resistance and tablets coated with the same
본 발명은 정제를 필름 코팅하기 위한 조성물 및 이러한 필름 코팅 조성물로 코팅된 정제에 관한 것이다. 특히, 본 발명은 빠른 속도로 코팅 가능하여 코팅에 소요되는 시간을 획기적으로 줄일 수 있으며, 코팅이 뛰어난 방습력을 갖는 필름 코팅용 조성물 및 이러한 조성물로 코팅된 정제에 관한 것이다.The present invention relates to compositions for film coating tablets and to tablets coated with such film coating compositions. In particular, the present invention can be coated at a high speed can significantly reduce the time required for the coating, and relates to a film coating composition and a tablet coated with such a composition having excellent moisture-proof coating.
최근 코팅제로 수용성 고분자를 이용한 수성 필름코팅이 나정을 보호하고, 안정성, 외관 등을 개선할 목적으로 종종 행해지고 있다. 이러한 필름코팅의 목적상 필름 코팅 조성물이 코팅된 정제의 안정성 확보에 바람직한 영향을 미쳐야 한다.Recently, an aqueous film coating using a water-soluble polymer as a coating agent is often performed for the purpose of protecting uncoated tablets and improving stability and appearance. For the purpose of such film coating, the film coating composition should have a desirable effect on ensuring the stability of the coated tablet.
한편, 코팅되는 필름이 두꺼울 경우 코팅 공정을 완료하는데 너무 많은 시간이 소요되어 비경제적이며, 이러한 코팅 공정 자체는 나정의 성상 및 안정성에 좋지 않은 영향을 미칠 수 있어 코팅 공정을 단축하는 것은 큰 경제적 가치를 가진다.On the other hand, when the film to be coated is thick, it takes too much time to complete the coating process, which is uneconomical, and this coating process itself may adversely affect the properties and stability of the uncoated tablets, so shortening the coating process is a great economic value. Has
특히, 수분에 불안정한 약물들이 많이 있으므로, 만약 필름 코팅이 뛰어난 방습력을 가진다면 매우 큰 장점이 된다. 그러나, 뛰어난 방습력과 코팅 속도는 종종 배치되어, 코팅 공정을 단축하면서 동시에 뛰어난 방습력을 갖도록 하는 것은 어렵다.In particular, since there are many drugs that are unstable in moisture, it is a great advantage if the film coating has excellent moisture proofing ability. However, excellent moisture and coating speeds are often arranged so that it is difficult to shorten the coating process and at the same time have excellent moisture resistance.
따라서 본 발명이 해결하고자 하는 과제는 빠른 코팅이 가능하며, 코팅된 나정(uncoated tablet)의 안정성 확보에 유리하고, 갈라짐 등의 코팅 층 외관 안정성이 개선된 필름코팅용 조성물을 제공하는 것이다. Therefore, the problem to be solved by the present invention is to provide a film coating composition that can be quickly coated, advantageous for securing the stability of the coated uncoated tablet, and improved coating layer appearance stability such as cracking.
특히, 본 발명은 빠른 코팅이 가능하면서도 뛰어난 방습력을 제공할 수 있는 필름코팅용 조성물을 제공하는 것이다. In particular, the present invention is to provide a film coating composition capable of providing a quick coating and excellent moisture proof.
본 발명이 해결하고자 하는 추가적인 과제는 이러한 필름코팅용 조성물로 코팅된 정제를 제공하는 것이다.A further problem to be solved by the present invention is to provide a tablet coated with such a film coating composition.
상기 과제를 해결하기 위하여, 본 출원은 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자를 포함하고, 상기 코팅용 고분자는 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체이며, 상기 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 각각 폴리비닐알콜 함량 대비 0.35 내지 0.65 중량부인 것을 특징으로 하는 필름코팅용 조성물, 바람직하게는 정제 필름코팅용 조성물을 제공한다. 바람직하게, 상기 조성물에 있어 조성물 내 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 각각 폴리비닐알콜 함량 대비 0.4 내지 0.6 중량부이다. 더욱 바람직하게, 코팅용 고분자로 2:0.9-1.1:0.9-1.1 (폴리비닐알콜:폴리비닐피롤리돈:메타아크릴산공중합체) 중량부로 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체이 사용된다.In order to solve the above problems, the present application comprises a coating polymer of 35-55% by weight relative to the total weight of the composition, the coating polymer is a polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer, the poly The content of the vinylpyrrolidone and methacrylic acid copolymer is 0.35 to 0.65 parts by weight relative to the polyvinyl alcohol content, respectively, and provides a composition for film coating, preferably a composition for tablet film coating. Preferably, the content of the polyvinylpyrrolidone and methacrylic acid copolymer in the composition is 0.4 to 0.6 parts by weight relative to the polyvinyl alcohol content, respectively. More preferably, polyvinyl alcohol, polyvinylpyrrolidone, and methacrylic acid copolymer are used as the coating polymer by weight of 2: 0.9-1.1: 0.9-1.1 (polyvinyl alcohol: polyvinylpyrrolidone: methacrylic acid copolymer) by weight. do.
바람직하게, 본 발명의 필름코팅용 조성물에 있어 메타아크릴산공중합체로는 메타아크릴산공중합체 타입 C, 타입 B, 타입 A 또는 이들의 혼합물이 사용될 수 있으며, 본 발명의 상기 목적상 타입 C가 가장 바람직하다.Preferably, in the film coating composition of the present invention, as methacrylic acid copolymer, methacrylic acid copolymer type C, type B, type A or a mixture thereof may be used, and type C is most preferable for the above purposes of the present invention. .
상기 코포비돈(비닐피롤리돈-비닐아세테이트 공중합체) 등 폴리비닐알콜과 유사하다고 알려진 물질들이 많이 있으나, 이들의 경우 끈적거리는 성질이 있어 본 발명의 목적상 적합하지 않았고, 또 코팅 때 온도를 너무 많이 높여서 약물의 안정성에 문제를 야기할 가능성도 있으며, 방습력도 그다지 바람직하지 못하였다. There are many substances known to be similar to polyvinyl alcohol, such as copovidone (vinylpyrrolidone-vinylacetate copolymer), but these are not suitable for the purposes of the present invention because they are sticky, and the temperature during coating is too high. It is also possible to raise the drug to raise the drug stability problem too much, moisture resistance was not very desirable.
바람직하게, 본 출원은 상기 필름코팅용 조성물에 있어 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자(폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체), 13-33 중량%의 산화티탄, 15-30 중량%의 탈크 및 0.2-8 중량%의 가소제를 포함하는, 필름코팅용 조성물을 제공한다. Preferably, the present application is 35-55% by weight of the coating polymer (polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer), 13-33% by weight of the composition for the film coating composition A composition for film coating is provided comprising titanium, 15-30 wt% talc and 0.2-8 wt% plasticizer.
바람직하게, 본 출원은 상기 필름코팅용 조성물에 있어 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자(폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체), 13-33 중량%의 산화티탄, 15-30 중량%의 탈크, 0.2-8 중량%의 가소제, 및 잔량(예를 들어, 0.1-8 중량%)의 기타 첨가제 (색소, 레시틴 등으로 이루어진 군으로부터 선택된 어느 하나 이상)를 포함하는, 필름코팅용 조성물을 제공한다.Preferably, the present application is 35-55% by weight of the coating polymer (polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer), 13-33% by weight of the composition for the film coating composition Titanium, 15-30 weight percent talc, 0.2-8 weight percent plasticizer, and the balance (e.g. 0.1-8 weight percent) other additives (any one or more selected from the group consisting of pigments, lecithin, and the like) To provide a film coating composition.
본 발명에 따른 상기 필름코팅용 조성물은 코팅 시간을 단축할 목적으로, 또 좋은 필름 코팅층이 형성되도록 하기 위해 코팅액 내 조성물의 함량을 높일 수 있다. 바람직하게, 상기 조성물은 최종 코팅액 기준으로 25-35 중량%가 되도록 코팅용매와 혼합하여 사용한다. 보다 바람직하게, 상기 조성물은 최종 코팅액 기준으로 28-32 중량%가 되도록 코팅용매와 혼합하여 사용한다. 가장 바람직하게, 상기 조성물은 최종 코팅액을 기준으로 29-31 중량%가 되도록 코팅용매와 혼합하여 사용하다. The film coating composition according to the present invention can increase the content of the composition in the coating liquid in order to shorten the coating time, and to form a good film coating layer. Preferably, the composition is used in combination with the coating solvent to be 25-35% by weight based on the final coating solution. More preferably, the composition is used in combination with the coating solvent to be 28-32% by weight based on the final coating solution. Most preferably, the composition is used in admixture with a coating solvent to be 29-31% by weight based on the final coating solution.
본 발명에 따른 필름코팅용 조성물은 코팅용매로 물, 바람직하게는 정제수를 사용하여 코팅액을 제조하게 되며, 이때 코팅용매와 조성물의 혼합비는 앞서 언급한 바와 같다.The film coating composition according to the present invention is to prepare a coating liquid using water, preferably purified water as a coating solvent, wherein the mixing ratio of the coating solvent and the composition is as mentioned above.
본 발명자는 다양한 연구를 수행한 결과, 상기 필름코팅 조성물을 이용하여 필름코팅 시 필름코팅 속도를 획기적으로 올릴 수 있으며, 코팅된 정제의 안정성 및 외관 유지에도 큰 개선이 있음을 확인하여 본 발명을 완성하였다. 특히, 본 발명의 필름코팅용 조성물은 흡습 방지 효과가 탁월하다.The inventors have conducted a variety of studies, using the film coating composition can significantly increase the film coating speed during film coating, confirming that there is a significant improvement in the stability and appearance of the coated tablets to complete the present invention It was. In particular, the film coating composition of the present invention is excellent in the moisture absorption prevention effect.
바람직하게, 본 발명에 따른 필름코팅용 조성물은 상기 기타 첨가제로 필름코팅 표면을 매끄럽게 하고, 필름을 유연하게 하는 역할을 하는 레시틴을 포함한다. Preferably, the film coating composition according to the present invention includes a lecithin that serves to smooth the film coating surface with the other additives, and to soften the film.
선택적으로, 본 발명의 필름코팅 조성물은 백색 계열의 착색제인 산화티탄 이외에 유색의 색소를 추가로 포함할 수 있다. 이러한 착색제로는 알루미늄레이크 계열의 색소들이 사용될 수 있다. Optionally, the film coating composition of the present invention may further include colored pigments in addition to titanium oxide, which is a white colorant. As such a colorant, dyes of aluminum lake series may be used.
본 발명에 따른 필름코팅용 조성물에 있어, 가소제로는 폴리에틸렌글리콜, 트리에틸시트레이트, 프로필렌글리콜 등이 사용될 수 있다.In the film coating composition according to the present invention, a plasticizer may be used polyethylene glycol, triethyl citrate, propylene glycol and the like.
본 발명에 따른 필름코팅용 조성물에 있어, 상기 폴리에틸렌글리콜로는 폴리에틸렌글리콜4000, 폴리에틸렌글리콜6000 등이 바람직하며, 특히 본 발명의 여러 목적상 폴리에틸렌글리콜6000이 더욱 바람직하다. 본 발명에 따른 필름코팅용 조성물에 있어, 상기 폴리비닐알콜로는 20℃에서 4 중량% 수용액으로 점도 측정 시 그 점도가 4-6 mPas인 폴리비닐알콜이 바람직하다. 본 발명에 따른 필름코팅용 조성물에 있어, 상기 폴리비닐피롤리돈으로는 폴리비닐피롤리돈 K-15, K-17, K-25, K-30 등이 바람직하다. 본 발명에 따른 필름코팅용 조성물에 있어, 상기 히프로멜로오스로는 히프로멜로오스 2910이 바람직하며, 20℃에서 2 중량% 수용액으로 점도 측정 시 그 점도가 10-20 mPas인 히프로멜로오스가 본 발명의 여러 목적상 더욱 바람직하다.In the film coating composition according to the present invention, the polyethylene glycol is preferably polyethylene glycol 4000, polyethylene glycol 6000, and the like, and polyethylene glycol 6000 is particularly preferable for various purposes of the present invention. In the film coating composition according to the present invention, the polyvinyl alcohol is preferably polyvinyl alcohol having a viscosity of 4-6 mPas when the viscosity is measured in a 4 wt% aqueous solution at 20 ° C. In the film coating composition according to the present invention, the polyvinylpyrrolidone is preferably polyvinylpyrrolidone K-15, K-17, K-25, K-30, or the like. In the film coating composition according to the present invention, the hypromellose is hypromellose 2910 is preferred, when the viscosity is measured by 20% aqueous solution of 2% by weight hypromellose having a viscosity of 10-20 mPas Is more preferred for various purposes of the present invention.
본 발명은 빠른 코팅이 가능하며, 코팅된 나정(uncoated tablet)의 안정성 확보에 유리하고, 갈라짐 등의 코팅 층 외관 안정성이 개선된 필름코팅용 조성물 및 이러한 필름코팅용 조성물로 코팅된 정제를 제공한다.The present invention provides a film coating composition and a tablet coated with such a film coating composition that can be quickly coated, advantageous to secure the stability of the coated uncoated tablet, and improves the appearance stability of the coating layer such as cracking. .
도 1 내지 3은 실험예 1의 샘플 A 내지 E의 안정성 평가 결과이다. 도 1은 정제의 외부 변화를 촬영한 사진들이며, 도 2는 정제의 변색 정도를 측정한 결과이고, 도 3은 정제의 갈라짐 정도를 측정한 결과이다.1 to 3 are results of stability evaluation of Samples A to E of Experimental Example 1. FIG. 1 is a photograph of the external changes of the tablet, Figure 2 is a result of measuring the degree of discoloration of the tablet, Figure 3 is a result of measuring the degree of cracking of the tablet.
도 4 내지 6은 퀵 플러스 필름코팅용 조성물의 평가 결과이다. 도 4는 이들의 외부 변화를 촬영한 사진들이며, 도 5는 정제의 변색 측정 결과이고, 도 6은 이들의 흡습 정도를 평가한 결과이다.4 to 6 are evaluation results of the composition for quick plus film coating. FIG. 4 is a photograph of these external changes, FIG. 5 is a result of measuring color change of the tablet, and FIG. 6 is a result of evaluating their degree of hygroscopicity.
이하, 본 발명의 이해를 돕기 위하여 실시예 등을 들어 상세하게 설명하기로 한다. 그러나, 본 발명에 따른 실시예들은 여러 가지 다른 형태로 변형될 수 있으며, 본 발명의 범위가 하기 실시예들에 한정되는 것으로 해석되어서는 안 된다. 본 발명의 실시예들은 본 발명이 속한 분야에서 평균적인 지식을 가진 자에게 본 발명을 보다 완전하게 설명하기 위해 제공되는 것이다.Hereinafter, examples and the like will be described in detail to help the understanding of the present invention. However, embodiments according to the present invention can be modified in many different forms, the scope of the invention should not be construed as limited to the following examples. The embodiments of the present invention are provided to more completely explain the present invention to those skilled in the art.
하기 언급되는 점도는 BROOKFIFLD DVE 점도계 (스핀들 RV S02, 60 rpm)로 약 1분간 점도 측정하여 나온 용액의 점도임.The viscosity mentioned below is the viscosity of the solution obtained by viscosity measurement for about 1 minute with a BROOKFIFLD DVE viscometer (spindle RV S02, 60 rpm).
비교예 1: 탭쉴드흰색 21W002Comparative example 1: tap shield white 21W002
하기 표 1의 조성 및 함량으로 필름코팅용 조성물인 비교예 1을 제조하였다.To Comparative Example 1 was prepared a film coating composition in the composition and content of Table 1.
원료명Raw material name 배합목적Purpose of Mixing 분량amount
폴리비닐알콜Polyvinyl alcohol 코팅제Coating 40.040.0
산화티탄Titanium oxide 착색제(색소)Colorant (pigment) 25.025.0
폴리에틸렌글리콜3350Polyethylene Glycol 3350 제피보조제Epidermal supplements 20.220.2
탈크Talc 제피보조제Epidermal supplements 14.814.8
총합total 100100
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 25 중량% 이상 넘어갈 경우 점도가 높아져 분사가 어렵고, 분사되더라도 표면이 너무 거칠어져 필름코팅에 부적절하였다. 상기 비교예 1의 적당한 코팅액 농도는 코팅액 총 중량 대비 약 20 중량%이었으며, 그 때의 점도는 약 90 cp이었다.상기 코팅 조성물 50 중량부와 정제수 200 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 2와 같이 코팅하였다. The composition was mixed with purified water to attempt a film coating to find a suitable coating solution concentration. The composition has a high viscosity when it exceeds 25% by weight relative to the total weight of the coating liquid, and the spraying is difficult, and even when sprayed, the surface is too rough, which is inappropriate for film coating. It was. The suitable coating solution concentration of Comparative Example 1 was about 20% by weight based on the total weight of the coating solution, and the viscosity was about 90 cp. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 200 parts by weight of purified water, and using a coating machine, BGB. Sample tablets were coated as shown in Table 2 using -1.
Figure PCTKR2019008107-appb-T000001
Figure PCTKR2019008107-appb-T000001
Coating weight는 10 mg이었으며, Coating Weight Gain은 2%이었고, 정제 중량은 527 mg에서 코팅 후 537 mg이었다. 총 코팅 시간은 15분이었고, 평균 분무 속도는 4.8 g/min이었다. 결과적으로 상기 조성물로 10 mg을 코팅하기 위하여 약 15분이 필요하였다. The coating weight was 10 mg, the coating weight gain was 2%, and the tablet weight was 527 mg after coating at 527 mg. The total coating time was 15 minutes and the average spray rate was 4.8 g / min. As a result, about 15 minutes were required to coat 10 mg with the composition.
비교예 2: 탭쉴드주황색 22O048Comparative Example 2: Tap Shield Orange 22O048
하기 표 3의 조성 및 함량으로 필름코팅용 조성물인 비교예 2를 제조하였다. To Comparative Example 2 was prepared for the film coating composition with the composition and content of Table 3.
원료명Raw material name 배합목적Purpose of Mixing 분량amount
폴리비닐알콜Polyvinyl alcohol 코팅제Coating 45.545.5
산화티탄Titanium oxide 착색제(색소)Colorant (pigment) 28.028.0
레시틴lecithin 제피보조제Epidermal supplements 2.02.0
탈크Talc 제피보조제Epidermal supplements 20.020.0
잔탄검Xanthan Gum 제피보조제 Epidermal supplements 0.50.5
알미늄레이크 Aluminum Lake 착색제coloring agent 잔량Remaining amount
총합total 100100
상기 코팅 조성물 15 중량부와 정제수 35 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 4와 같이 코팅하였다. A coating solution was prepared by mixing 15 parts by weight of the coating composition and 35 parts by weight of purified water, and sample tablets were coated using BGB-1 as a coater as shown in Table 4 below.
Figure PCTKR2019008107-appb-T000002
Figure PCTKR2019008107-appb-T000002
Coating weight는 36 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 714 mg에서 코팅 후 750 mg이었다. 총 코팅 시간은 35분이었고, 평균 분무 속도는 7.2 g/min이었다. 결과적으로 상기 조성물로 36 mg을 코팅하기 위하여 약 35분이 필요하였다. 코팅 과정 중에 스티킹(sticking) 현상이 많이 발생하여 코팅 공정을 세팅하기가 쉽지 않으며, 상대적으로 코팅에 많은 시간이 소요되었다. The coating weight was 36 mg, the coating weight gain was 5%, and the tablet weight was 714 mg after coating at 714 mg. The total coating time was 35 minutes and the average spray rate was 7.2 g / min. As a result, about 35 minutes were required to coat 36 mg with the composition. Many sticking phenomenon occurs during the coating process, so it is not easy to set the coating process, and the coating takes a long time.
실시예 1: 탭쉴드주황색 71O154Example 1: Tap Shield Orange 71O154
하기 표 5의 조성 및 함량으로 필름코팅용 조성물인 실시예 1을 제조하였다. To prepare a composition for film coating Example 1 in the composition and content of Table 5.
원료명Raw material name 배합목적Purpose of Mixing 분량amount 비고Remarks
산화티탄Titanium oxide 착색제(색소)Colorant (pigment) 23.023.0
폴리에틸렌글리콜6000Polyethylene Glycol 6000 제피보조제Epidermal supplements 20.220.2
폴리비닐알콜Polyvinyl alcohol 코팅제Coating 20.020.0
폴리비닐피롤리돈Polyvinylpyrrolidone 코팅제Coating 20.020.0
탈크Talc 제피보조제Epidermal supplements 14.814.8
히프로멜로오스Hypromellose 코팅제Coating 1.01.0 치환도: 2910, 점도: 15mPasDegree of substitution: 2910, Viscosity: 15 mPas
알루미늄레이크 색소 Aluminum Lake Pigment 착색제(색소)Colorant (pigment) 잔량Remaining amount 황색4호Yellow No. 4
총합total 100100
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 약 30 중량%에서 필름코팅에 적절하였다. 상기 코팅액의 점도는 약 99 cp이었다.상기 코팅 조성물 50 중량부와 정제수 116 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 6과 같이 코팅하였다. The composition was mixed with purified water to attempt film coating to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight relative to the total weight of the coating solution. The viscosity of the coating solution was about 99 cp. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water, and sample tablets were coated using BGB-1 using a coater as shown in Table 6 below.
Figure PCTKR2019008107-appb-T000003
Figure PCTKR2019008107-appb-T000003
Coating weight는 35 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 9분이었고, 평균 분무 속도는 8.0 g/min이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다. The coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 707 mg after coating at 707 mg. The total coating time was 9 minutes and the average spray rate was 8.0 g / min. As a result, about 9 minutes were needed to coat 35 mg with the composition.
실시예 2: 탭쉴드주황색 71O155Example 2: Tap Shield Orange 71O155
하기 표 7의 조성 및 함량으로 필름코팅용 조성물인 실시예 2를 제조하였다.To prepare a composition for film coating Example 2 in the composition and content of Table 7.
원료명Raw material name 배합목적Purpose of Mixing 분량amount 비고Remarks
산화티탄Titanium oxide 착색제(색소)Colorant (pigment) 24.524.5
폴리비닐알콜Polyvinyl alcohol 코팅제Coating 22.7622.76
폴리비닐피롤리돈Polyvinylpyrrolidone 코팅제Coating 22.7622.76 K-30K-30
탈크Talc 제피보조제Epidermal supplements 21.521.5
레시틴lecithin 제피보조제Epidermal supplements 2.02.0 대두레시틴Soy Lecithin
잔탄검Xanthan Gum 제피보조제Epidermal supplements 0.480.48
알루미늄레이크 색소Aluminum Lake Pigment 착색제(색소)Colorant (pigment) 잔량Remaining amount
총합total 100100
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 약 30 중량%에서 필름코팅에 적절하였다. 상기 코팅액의 점도는 약 120 cp이었다.상기 코팅 조성물 50 중량부와 정제수 116 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 8과 같이 코팅하였다. The composition was mixed with purified water to attempt film coating to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight relative to the total weight of the coating solution. The viscosity of the coating solution was about 120 cp. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water.
Figure PCTKR2019008107-appb-T000004
Figure PCTKR2019008107-appb-T000004
Coating weight는 35 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 9분이었고, 평균 분무 속도는 8.0 g/min이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다. The coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 707 mg after coating at 707 mg. The total coating time was 9 minutes and the average spray rate was 8.0 g / min. As a result, about 9 minutes were needed to coat 35 mg with the composition.
실시예 3: 탭쉴드주황색 71O156Example 3: Tap Shield Orange 71O156
하기 표 9의 조성 및 함량으로 필름코팅용 조성물인 실시예 3을 제조하였다. To prepare a composition for film coating Example 3 in the composition and content of Table 9.
원료명Raw material name 배합목적Purpose of Mixing 분량amount 비고Remarks
산화티탄Titanium oxide 착색제(색소)Colorant (pigment) 24.524.5
폴리비닐알콜Polyvinyl alcohol 코팅제Coating 22.7622.76
폴리비닐피롤리돈Polyvinylpyrrolidone 코팅제Coating 22.7622.76 K-30K-30
탈크Talc 제피보조제Epidermal supplements 21.521.5
폴리에틸렌글리콜6000Polyethylene Glycol 6000 제피보조제Epidermal supplements 2.482.48
알루미늄레이크 색소Aluminum Lake Pigment 착색제(색소)Colorant (pigment) 잔량Remaining amount 적색40호Red 40
총합total 100100
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 약 30 중량%에서 필름코팅에 적절하였다. 상기 코팅액의 점도는 약 125 cp이었다.상기 코팅 조성물 50 중량부와 정제수 116 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 9와 같이 코팅하였다. The composition was mixed with purified water to attempt film coating to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight relative to the total weight of the coating solution. The viscosity of the coating solution was about 125 cp. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water.
Figure PCTKR2019008107-appb-T000005
Figure PCTKR2019008107-appb-T000005
Coating weight는 35 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 9분이었고, 평균 분무 속도는 8.0 g/min이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다. The coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 707 mg after coating at 707 mg. The total coating time was about 9 minutes and the average spray rate was 8.0 g / min. As a result, about 9 minutes were needed to coat 35 mg with the composition.
실험예 1: 폴리비닐피롤리돈의 혼합비(중량비)에 따른 영향 평가Experimental Example 1: Evaluation of the effect of the mixing ratio (weight ratio) of polyvinylpyrrolidone
비교예 1 처방에서 폴리비닐알콜의 일정 부분을 폴리비닐피롤리돈으로 치환하면서 비교예 1과 동일한 방법으로 나정 필름코팅을 수행하였다. 폴리비닐피롤리돈의 치환 비율을 하기 표 11과 같았다. Comparative Example 1 Uncoated film coating was performed in the same manner as in Comparative Example 1 while replacing a portion of polyvinyl alcohol with polyvinylpyrrolidone. Substitution ratios of the polyvinylpyrrolidone were as shown in Table 11 below.
샘플명Sample name 폴리머 비율(%)% Polymer 용질 비율(%)Solute fraction (%) 용액 점도(cp)Solution viscosity (cp) 코팅량(%)Coating amount (%)
폴리비닐알콜Polyvinyl alcohol 폴리비닐피롤리돈Polyvinylpyrrolidone
샘플 A(비교예 1)Sample A (Comparative Example 1) 100100 00 2020 90.090.0 44
샘플 BSample B 7575 2525 2020 120.0120.0 44
샘플 CSample C 5050 5050 3030 352.0352.0 44
샘플 DSample D 2525 7575 3030 208.0208.0 44
샘플 E Sample E 00 100100 3030 152.0152.0 44
이후, 항온항습기(모델명: YHS-250SC)에서 온도 40℃, 습도 75RH의 가혹한 조건으로 보관하면서 필름코팅정의 안정성을 평가하였다. 구체적으로 보관 시작 후 1시간, 2시간, 4시간, 6시간, 8시간, 및 24시간에 정제의 변색과 갈라짐을 관찰하였다. 그 결과를 도 1 내지 3에 나타내었다. 도 1은 정제의 외부 변화를 촬영한 사진들이며, 도 2는 정제의 변색 정도를 측정한 결과이고, 도 3은 정제의 갈라짐 정도를 측정한 결과이다. Then, the stability of the film-coated tablet was evaluated while storing in a constant temperature and humidity chamber (model name: YHS-250SC) at a temperature of 40 ℃, harsh conditions of 75RH. Specifically, discoloration and cracking of the tablets were observed at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours after the start of storage. The results are shown in FIGS. 1 is a photograph of the external changes of the tablet, Figure 2 is a result of measuring the degree of discoloration of the tablet, Figure 3 is a result of measuring the degree of cracking of the tablet.
도 1 및 도 2의 결과로부터 알 수 있는 바와 같이, 폴리비닐피롤리돈은 변색에 다소 취약한 것으로 나타났다. 다만, 특이하게도 폴리비닐알콜과 폴리비닐피롤리돈의 함량이 유사한 비율로 혼합될 경우 변색 안정성이 상대적으로 양호하였다. As can be seen from the results of FIGS. 1 and 2, polyvinylpyrrolidone was found to be somewhat vulnerable to discoloration. However, specifically, when the content of polyvinyl alcohol and polyvinylpyrrolidone were mixed in a similar ratio, discoloration stability was relatively good.
도 1 및 도 3에 나타나는 바와 같이, 샘플 A, B, 및 C는 갈라짐이 없었으며, 폴리비닐알콜보다 폴리비닐피롤리돈의 함량이 매우 높은 샘플 D 및 E에서만 코팅 기재가 녹아 내리고 갈라지는 현상을 보였다.As shown in Figures 1 and 3, the samples A, B, and C had no cracking, and the coating substrate melted and cracked only in the samples D and E having a higher content of polyvinylpyrrolidone than polyvinyl alcohol. Seemed.
실험예 2: 탭쉴드 퀵 플러스 평가Experimental Example 2: Tap Shield Quick Plus Evaluation
하기 표 12와 같이 비교예 및 실시예들을 제조하였으며, 비교평가를 위해 나정은 동일한 나정(멀티비타민 제제인 임팩타민 프리미엄 정제의 나정을 이용함)을 사용하였다. 각각의 코팅 조성물은 표 13 (1차 코팅기재) 및 14 (2차 코팅기재)에 나타내었다. 조성물을 용해 또는 미세하게 현탁시키기 위한 코팅용매로는 물을 사용하였다. Comparative Examples and Examples were prepared as shown in Table 12 below, and for the purpose of comparative evaluation, uncoated tablets were used for uncoated tablets (coated tablets of impact vitamin premium tablets, a multivitamin preparation). Each coating composition is shown in Table 13 (primary coating substrate) and 14 (secondary coating substrate). Water was used as a coating solvent for dissolving or finely suspending the composition.
코팅액 총중량 대비 탭쉴드클리어(71C152)는 8.5 중량%, 탭쉴드흰색은 20 중량%, 탭 쉴드 퀵은 30 중량%, 탭쉴드 퀵 플러스는 30 중량%가 되도록 물과 혼합하여 코팅액을 제조하였다. The coating liquid was mixed with water so that the tap shield clear (71C152) was 8.5 wt%, the tap shield white was 20 wt%, the tap shield quick was 30 wt%, and the tap shield quick plus was 30 wt% based on the total weight of the coating liquid.
샘플명Sample name 1차 코팅Primary coating 코팅량(%)Coating amount (%) 2차 코팅Secondary coating 코팅량(%)Coating amount (%)
AA 탭쉴드클리어(71C152)Tap Shield Clear (71C152) 0.75%0.75% 탭쉴드흰색(11W001)Tap shield white (11W001) 5.0%5.0%
BB 탭쉴드흰색(21W002)Tap shield white (21W002)
CC 탭쉴드흰색(22W005)Tap shield white (22W005)
DD 탭쉴드 퀵 Tap Shield Quick
EE 탭쉴드 퀵 플러스 Tap Shield Quick Plus
원료명Raw material name 탭쉴드클리어(71C152)Tap Shield Clear (71C152)
히프로멜로오스2910 6mPasHypromellose 2910 6mPas 90.00090.000
폴리에틸렌글리콜3350Polyethylene Glycol 3350 5.0005.000
탈크Talc 3.0003.000
에틸셀룰로오스 10mPasEthyl Cellulose 10mPas 1.0001.000
폴리비닐피롤리돈 K-30Polyvinylpyrrolidone K-30 1.0001.000
총합total 100100
원료명Raw material name 탭쉴드흰색(11W001)Tap shield white (11W001) 탭쉴드흰색(21W002)Tap shield white (21W002) 탭쉴드흰색(22W005)Tap shield white (22W005) 탭쉴드 퀵 Tap Shield Quick 탭쉴드 퀵 플러스 Tap Shield Quick Plus
히프로멜로오스 6mPasHypromellose 6 mPas 62.50062.500 -- -- -- --
폴리에틸렌글리콜400Polyethylene Glycol 400 6.2506.250 -- -- -- --
산화티탄Titanium oxide 31.25031.250 25.00025.000 32.00032.000 22.76022.760 22.76022.760
폴리비닐알콜Polyvinyl alcohol -- 40.00040.000 45.52045.520 22.76022.760 22.76022.760
탈크Talc -- 14.80014.800 20.00020.000 26.00026.000 26.00026.000
레시틴lecithin -- -- 2.0002.000 3.5003.500 3.5003.500
잔탄검Xanthan Gum -- -- 0.4800.480 -- --
폴리비닐피롤리돈Polyvinylpyrrolidone -- -- -- 22.76022.760 11.38011.380
메타아크릴산공중합체 TYPE C (유드라짓 L100-55)Methacrylic acid copolymer TYPE C (Eudragit L100-55) -- -- -- -- 11.38011.380
폴리에틸렌글리콜3350Polyethylene Glycol 3350 -- 20.20020.200 -- -- --
폴리에틸렌글리콜6000Polyethylene Glycol 6000 -- -- -- 2.2202.220 2.2202.220
총합total 100100 100100 100100 100100 100100
각각의 코팅 조건은 하기 표 15와 같았다.Each coating condition was as Table 15 below.
항목(평균)Item (average) 탭쉴드클리어(71C152)Tap Shield Clear (71C152) 탭쉴드흰색 (11W001)탭쉴드흰색(21W002)Tap Shield White (11W001) Tap Shield White (21W002) 탭쉴드흰색(22W005)Tap shield white (22W005) 탭쉴드 퀵 탭쉴드 퀵 플러스Tap Shield Quick Tap Shield Quick Plus
Inlet temperatureInlet temperature 약 64℃About 64 ℃ 약 74℃About 74 ℃ 약 85℃About 85 ℃ 약 74℃About 74 ℃
Exhaust temperatureExhaust temperature 약 33℃About 33 ℃ 약 40℃About 40 ℃ 약 43℃Approximately 43 degrees Celsius 약 40℃About 40 ℃
Spray rateSpray rate 약 8.0 g/minAbout 8.0 g / min 약 7.2 g/min7.2 g / min 약 7.2 g/min7.2 g / min 약 7.2 g/min7.2 g / min
Pump SpeedPump speed 약 9 rpmAbout 9 rpm 약 8 rpmAbout 8 rpm 약 7.9 rpmAbout 7.9 rpm 약 8 rpmAbout 8 rpm
Pan speedPan speed 약 15 rpmAbout 15 rpm 약 16 rpmAbout 16 rpm 약 13 rpmAbout 13 rpm 약 16 rpmAbout 16 rpm
Atomizing air pressureAtomizing air pressure 약 0.4 barAbout 0.4 bar 약 1.0 bar1.0 bar 약 1.1 bar1.1 bar 약 1.1 bar1.1 bar
Pattern Air pressurePattern Air pressure 약 0.4 barAbout 0.4 bar 약 1.0 bar1.0 bar 약 1.1 bar1.1 bar 약 1.1 bar1.1 bar
Air flowAir flow 약 180 m3/hrAbout 180 m 3 / hr 약 180 m3/hrAbout 180 m 3 / hr 약 180 m3/hrAbout 180 m 3 / hr 약 180 m3/hrAbout 180 m 3 / hr
Coating weightCoating weight 7 mg7 mg 35 mg35 mg 35 mg35 mg 35 mg35 mg
Coating Weight Gain Coating Weight Gain 1 중량%1 wt% 5 중량%5 wt% 5 중량%5 wt% 5 중량%5 wt%
탭쉴드클리어(71C152)의 경우 정제 중량은 700 mg에서 코팅 후 707 mg이었다. 총 코팅 시간은 약 9분이었다. 결과적으로 상기 조성물로 7 mg을 코팅하기 위하여 약 9분이 필요하였다.탭쉴드흰색(11W001)의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 40분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 40분이 필요하였다. 탭쉴드흰색(11W001) 코팅 조성물의 경우 코팅액 중 코팅조성물 함량이 12 중량%를 넘을 경우 분무가 잘 안되고 스티킹(sticking) 현상이 발생하였으며, 방습력도 현저히 좋지 않았다. For the tap shield clear (71C152) the tablet weight was 700 mg after coating at 707 mg. The total coating time was about 9 minutes. As a result, about 9 minutes were required to coat 7 mg with the composition. For the tab shield white (11W001), the tablet weight was 742 mg after coating at 707 mg. The total coating time was about 40 minutes. As a result, about 40 minutes were required to coat 35 mg with the composition. In the case of the coating composition of the tab shield white (11W001), when the coating composition content of the coating liquid exceeds 12% by weight, spraying is not good and sticking occurs, and moisture proofing power is also not very good.
탭쉴드흰색(21W002)의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 20분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 20분이 필요하였다. 탭쉴드흰색(21W002) 코팅 조성물의 경우 코팅 시 스티킹(sticking) 현상이 발생하고, 코팅 질(quality)이 떨어져 분무 속도를 더 이상 높이기 어려웠다. Tablet weights were 742 mg after coating at 707 mg for the tab shield white (21W002). Total coating time was about 20 minutes. As a result, about 20 minutes were required to coat 35 mg with the composition. In the case of the tap shield white (21W002) coating composition, a sticking phenomenon occurs during the coating, and the coating quality is poor, so that it is difficult to increase the spraying speed.
탭쉴드흰색(22W005)의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 40분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 20분이 필요하였다. 탭쉴드흰색(22W005) 코팅 조성물의 경우 코팅 시 스티킹(sticking) 현상이 발생하고, 코팅 질(quality)이 떨어져 분무 속도를 더 이상 높이기 어려웠다.For the tab shield white (22W005) the tablet weight was 742 mg after coating at 707 mg. The total coating time was about 40 minutes. As a result, about 20 minutes were required to coat 35 mg with the composition. In the case of the tap shield white (22W005) coating composition, a sticking phenomenon occurs during coating, and the coating quality is poor, so that it is difficult to increase the spraying speed.
탭쉴드 퀵 및 탭쉴드 퀵 플러스의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 9분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다.Tablet weights from 707 mg to 742 mg after coating for TapShield Quick and TapShield Quick Plus. The total coating time was about 9 minutes. As a result, about 9 minutes were needed to coat 35 mg with the composition.
상기 비교예 및 실시예 샘플들을 항온항습기(모델명: YHS-250SC)(40℃, 75RH)에서 보관하면서, 6시간, 12시간, 24시간, 48시간, 및 72시간에 정제의 변색과 흡습을 관찰하였다. 그 결과를 도 4 내지 6에 나타내었다. Observing the discoloration and hygroscopicity of the tablets at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours while the samples of Comparative Examples and Examples were stored in a thermo-hygrostat (model name: YHS-250SC) (40 ° C, 75RH). It was. The results are shown in FIGS. 4 to 6.
도 4 내지 6에 나타나는 바와 같이, 본 발명에 따른 필름 코팅 조성물은 빠른 시간 내에 코팅이 가능하여 코팅 공정을 획기적으로 단축할 수 있으면서도 동시에 나정을 보호하는데 있어 뛰어난 안정성을 보여주었다.As shown in Figures 4 to 6, the film coating composition according to the present invention can be coated in a short time to significantly shorten the coating process while showing excellent stability in protecting the uncoated at the same time.

Claims (8)

  1. 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자를 포함하고,35-55% by weight of the coating polymer relative to the total weight of the composition,
    상기 코팅용 고분자는 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체이며, The coating polymer is polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer,
    상기 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 각각 폴리비닐알콜 함량 대비 0.35 내지 0.65 중량부인 것을 특징으로 하는 필름코팅용 조성물.The content of the polyvinylpyrrolidone and methacrylic acid copolymer is a film coating composition, characterized in that 0.35 to 0.65 parts by weight relative to the polyvinyl alcohol content, respectively.
  2. 제1항에 있어서, 상기 메타아크릴산공중합체는 메타아크릴산공중합체 타입 C인, 필름코팅용 조성물. The film coating composition of claim 1, wherein the methacrylic acid copolymer is methacrylic acid copolymer type C.
  3. 제1항에 있어서, 상기 조성물은 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자, 13-33 중량%의 산화티탄, 15-30 중량%의 탈크 및 0.2-8 중량%의 가소제를 포함하는, 필름코팅용 조성물.The composition of claim 1, wherein the composition comprises 35-55 wt% coating polymer, 13-33 wt% titanium oxide, 15-30 wt% talc, and 0.2-8 wt% plasticizer, based on the total weight of the composition. , Composition for film coating.
  4. 제1항에 있어서, 상기 조성물은 색소 및 레시틴로 이루어진 군으로부터 선택된 어느 하나 이상을 조성물 총 중량 대비 0.1-8 중량% 포함하는, 필름코팅용 조성물.According to claim 1, wherein the composition comprises at least one selected from the group consisting of pigments and lecithin 0.1-8% by weight relative to the total weight of the composition, the film coating composition.
  5. 제1항 내지 제4항 중 어느 한 항에 있어서, 상기 조성물은 최종 코팅액 기준으로 25-35 중량%가 되도록 코팅용매와 혼합하여 사용하는 것인, 필름코팅용 조성물.The film coating composition according to any one of claims 1 to 4, wherein the composition is used in combination with a coating solvent to be 25-35% by weight based on the final coating solution.
  6. 제5항에 있어서, 상기 조성물은 최종 코팅액 기준으로 28-32 중량%가 되도록 코팅용매와 혼합하여 사용하는 것인, 필름코팅용 조성물.The composition of claim 5, wherein the composition is used in combination with a coating solvent to be 28-32% by weight based on the final coating solution.
  7. 제5항에 있어서, 상기 코팅용매는 물인, 필름코팅용 조성물. The composition of claim 5, wherein the coating solvent is water.
  8. 제1항 내지 제4항 중 어느 한 항에 있어서, 상기 조성물 내 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 2:0.9-1.1:0.9-1.1 (폴리비닐알콜: 폴리비닐피롤리돈:메타아크릴산공중합체)인, 필름코팅용 조성물.The content of polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer in the composition is 2: 0.9-1.1: 0.9-1.1 (polyvinyl alcohol: polyvinyl). Pyrrolidone: methacrylic acid copolymer), a film coating composition.
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